MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 100
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Event or Problem Description
During shift check, the autopulse platform (sn (b)(4)) failed to power up.The customer tried two good working li-ion autopulse batteries without any success.No device malfunction was reported on the batteries.No patient involvement.
Additional Manufacturer Narrative
The customer's reported complaint of the autopulse platform (sn (b)(6) failed to power up was not confirmed during the functional testing and the archive data review.The autopulse platform was able to power up during the functional testing, and the reported complaint could not be replicated.During visual inspection, there was no physical damage observed on the autopulse platform.The platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering on, unrelated to the reported complaint.The brake gap inspection was performed and verified the brake gap was within the specification.Autopulse (ap) vision software was used to clear the observed system error.Unrelated to the reported complaint, the archive data revealed a system error 139 (unable to hold compression position) message around the reported date.The autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with four good known test batteries until discharged without any fault or error.

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 11269993
• Report Number: 3010617000-2021-00097
• Device Sequence Number: 11623206
• Product Code: DRM
• UDI-Device Identifier: 00849111001090
• UDI-Public: 00849111001090
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1